Galderma Demonstrates Robust Aesthetic Innovation Pipeline with Initiation of Seven New Clinical Studies

FORT WORTH, Texas, Oct. 24, 2019 /PRNewswire/ -- Galderma, a global leader in skin health focused on developing innovative aesthetic solutions, continues its strong investment in products and research that advance the aesthetics industry with seven new clinical studies recently initiated.

“We are proud of our continued investment in Research and Development and eager to share findings related to multiple clinical studies supporting our aesthetic portfolio at the ASDS meeting,” Alisa Lask, Vice President and General Manager of Galderma U.S. Aesthetics. “Our innovation pipeline is poised to deliver aesthetic solutions to meet growing patient needs and help drive market expansion.”

Galderma will present a breadth of new research across the neurotoxin and dermal fillers portfolio, including data supporting the expansion of XpresHAn Technology during the 2019 American Society for Dermatologic Surgery Annual Meeting on October 24-26 in Chicago, Illinois. The research will highlight Phase 3 results to support FDA submission for an innovative treatment for lip augmentation, as well as findings on measuring the flexibility of dermal fillers and ratings from the general public perceiving natural-looking results with XpresHAn technology fillers. Further, several studies evaluating the company’s neurotoxin portfolio, including patient satisfaction and duration, will be presented during the meeting.

Galderma continues to support female clinical trial investigators and has more than doubled the number of female clinical investigators in company-sponsored trials since 2014. Today, women hold nearly 50 percent of Galderma’s clinical investigator roles.

“Our comprehensive clinical research program is backed by a robust investment plan to support innovation over the next five years,” said Xiaoming Lin, Global Head of Aesthetic Development at Galderma. “Globally, Galderma currently has enrolled more than 6,000 patients across approximately 80 clinical trial sites with a total of 17 clinical studies underway.”

Galderma is also initiating clinical studies to support potential, new aesthetic indications including a tear trough indication for Restylane^®, a facial wrinkles indication for Sculptra^® Aesthetic, several studies supporting an investigational liquid neurotoxin and a Phase 2 study to evaluate Dysport^® (abobotulinumtoxinA) for Injection* in the platysmal bands.

*Please see full Important Safety Information for Dysport^®, including Distant Spread of Toxin Effect Boxed Warning, at the end of this document

“My passion is to bridge evolving aesthetic trends with research to ensure all clinicians have access to quality products that reflect true innovation and promote optimal patient outcomes,” said Jeremy B. Green M.D., board-certified dermatologist at Skin Associates of South Florida and a primary investigator for Galderma’s clinical trials. “I am motivated to work with a company that is committed to investing in innovations that advance our industry.”

For additional information on Galderma’s featured presentations, please see below for details:

Oral Presentations:

• Evaluation of QM1114, a novel, ready-to-use liquid botulinum toxin, in aesthetic treatment of glabellar lines (QM1114 Phase 2 Data) – Dr. Mark Nestor (Oral Abstracts: Cosmetic Dermatologic Surgery Session: Thursday, October 24, 2019, at 2:35 PM – 3:30 PM)
• A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study to Evaluate the Effectiveness and Safety of HA_RK versus a Comparator in the Augmentation of Soft Tissue Fullness of the Lip – Dr. Sue Ellen Cox (Oral Abstracts: Cosmetic Dermatologic Surgery Session: Thursday, October 24, 2019, at 2:35 PM – 3:30 PM)
• AbobotulinumtoxinA efficacy lasts up to 5 months in the treatment of glabellar lines – Dr. Joel Cohen (Oral Abstracts: International Session: Saturday, October 26, 2019, at 3:00 PM – 4:00 PM)
• A novel method to study the firmness and flexibility of hyaluronic acid fillers – Dr. Jeremy Green (Oral Abstracts: Cosmetic Dermatologic Surgery: Saturday, October 26, 2019 from 1:45 PM—2:45 PM)
• Lay rater image evaluation of naturalness and first impression projected following treatment of lower face wrinkles – Dr. Sabrina Fabi (Oral Abstracts: Cosmetic Dermatologic Surgery: Saturday, October 26, 2019 from 1:45 PM—2:45 PM)
• Immediate use after reconstitution of a biostimulatory poly-L-lactic acid injectable implant – Dr. Melanie Palm (Oral Abstracts: Best of Oral Abstracts and CERG, Brandt: Thursday, October 24, 2019 from 1:30 PM—2:25 PM)

Poster Presentations:

• Efficacy and Safety of 2 Injection Volumes of AbobotulinumtoxinA in Treatment of Glabellar Lines: Data from Two Studies – Dr. Joely Kaufman-Janette (E-Poster)
• High Subject Satisfaction After Aesthetic Treatment of Glabellar Lines with AbobotulinumtoxinA in Up to Three Injection Cycles – Dr. Alessandra Nogueira (E-Poster)
• Systematic Literature Review Examining Efficacy of AbobotulinumtoxinA for Aesthetic Indications – Dr. Joel Cohen (E-Poster)
• Interim Results from a Multi-Center Study to Evaluate Subject Satisfaction with a Twice-Yearly Re-Treatment Schedule for AbobotulinumtoxinA – Dr. Joel Schlessinger (Industry-sponsored poster)

About Galderma

Galderma, the world’s largest independent global skin health company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven innovative solutions for the skin. For more information, please visit www.galderma.com.

To earn exclusive rewards, bonuses and discounts on Galderma’s aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.

Follow Galderma on Instagram at @GaldermaAestheticsUSA.

Global Contacts

Sébastien Cros
Head of Corporate Communications
media@galderma.com

Isabella Laihorinne Smedh
Head of PR & Communications, Aesthetics
Isabella.LaihorinneSmedh@Galderma.com
+46761811713

U.S. Contact

Victoria Smurro
Marina Maher Communications
vsmurro@hellommc.com
212.485.6816

Indication:

Dysport^® (abobotulinumtoxinA) for Injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients ˂ 65 years of age.

Important Safety Information Distant

Spread of Toxin Effect
Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.

CONTRAINDICATIONS

• Hypersensitivity to any botulinum toxin product or excipients
• Allergy to cow’s milk protein
• Infection at the proposed injection site(s)

WARNINGS AND PRECAUTIONS

• The potency Units of Dysport are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Dysport cannot be compared to or converted into units of any other botulinum toxin products.
• Recommended dose and frequency of administration should not be exceeded.
• Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties, or serious hypersensitivity reactions.
• Dry eye, reduced tear production, reduced blinking, and corneal disorders, may occur with the use of Dysport.
• Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.
• Dysport contains human albumin. There is a risk for transmission of Creutzfeldt-Jakob disease (CJD) however, no cases of transmission of viral diseases or CJD have ever been identified for albumin.

ADVERSE REACTIONS

• In clinical studies, the most frequently reported adverse events (≥2%) were nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, eyelid ptosis, sinusitis, nausea, and blood present in urine.

DRUG INTERACTIONS

• Concomitant use of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of the botulinum toxin may be potentiated.
• Anticholinergic drugs may potentiate systemic anticholinergic effects.
• Excessive weakness may be exacerbated by administration of different botulinum neurotoxins and/or muscle relaxants during the course of treatment with Dysport.

USE IN SPECIFIC POPULATIONS

• Dysport is not recommended for use in children or pregnant women.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Dysport Full Prescribing Information including Medication Guide at DysportUSA.com

Important Safety Information

Indication: Sculptra^® Aesthetic (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems as a single regimen for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

Sculptra^® Aesthetic should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.

Sculptra^® Aesthetic has unique injection requirements and should only be used by a trained physician. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.

Sculptra^® Aesthetic should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra^® Aesthetic should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.

The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported.

Sculptra^® Aesthetic is available only through a licensed practitioner. View the complete instructions for use at www.SculptraAesthetic.com.

Important Safety Information

The Restylane family of products includes Restylane^®, Restylane-L^®, Restylane^® Lyft with Lidocaine, Restylane^® Silk, Restylane^® Refyne, and Restylane^® Defyne.

APPROVED USES
Restylane^® and Restylane-L^® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane^® and Restylane-L^® are also indicated for injection into the lips in patients over the age of 21.

Restylane^® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane® Lyft with Lidocaine is also indicated for injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21.

Restylane^® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.

Restylane^® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Restylane^® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Are there any reasons why I should not use products within the Restylane® family? (Contraindications)

To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:

• You have severe allergies with a history of severe reactions (anaphylaxis)
• You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
• You are prone to bleeding or have been diagnosed with a bleeding disorder

Are there other precautions that I should discuss with my doctor?

• Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
• Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Restylane® Lyft with Lidocaine is also intended for injection in the dorsal hand to correct volume loss. Treatments in other areas of the face or body have not been evaluated in clinical studies.
• The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies.
• Tell your doctor if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general.
• Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
• Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
• Tell your doctor if you are on any medications to decrease your body’s immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site.
• Tell your doctor if you are using any “blood thinners” such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site.
• The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse.
• Tell your doctor if you have diseases, injuries, or disabilities of the hand.

What are the possible side effects?

The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.

One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.

As with all skin injection procedures, there is a risk of infection.

To report a side effect with any of the Restylane products, please call Galderma Laboratories, L.P. at 1-855-425-8722.

The Restylane family of products is available only through a licensed practitioner. Complete Instructions for Use are available at www.RestylaneUSA.com.

USMP/DYS/0261/1019

© 2019 Galderma Laboratories, L.P.
The Dysport^® trademark is under license. All trademarks are the property of their respective owners.

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